CIOMS I Form

The CIOMS 1 Form with links to the ICH E2B (R2 and R3) guidelines can be downloaded here.

In 1977, a CIOMS Conference on “Trends and Prospects in Drug Research and Development” recommended that, by offering an independent forum, CIOMS should facilitate discussion of policy matters between the research-based pharmaceutical companies and national regulatory authorities, and, when indicated convene groups of experts to make recommendations on specific issues.

In 1986, CIOMS set up its first Working Group on pharmacovigilance, a Working Group on International Reporting of Adverse Drug Reactions to explore means of coordinating and standardizing international adverse drug reporting by pharmaceutical manufacturers to regulatory authorities. Its agenda was limited to post-marketing reporting of adverse drug reactions occurring in one country and which the pharmaceutical industry should report to regulatory authorities in other countries where the drug is also marketed. The Working Group devised a method for the reporting by manufacturers of suspected adverse drug reactions which included standardized definitions, procedures and format. The report contains the CIOMS reporting Form 1, which for the first time set the minimum standard for reporting. The CIOMS Form 1 was later the basis for establishing many of the national reporting forms.

The initial report of the Working Group was published in 1987, and the final report of the CIOMS Working Group I “International Reporting of Adverse Drug Reactions” was published in 1990. In 1992 the CIOMS Working Group II report “International Reporting of Periodic Drug-Safety Update Summaries” was published. Since then more than ten Working Groups, including the recent two Working Groups dealing with vaccine safety have completed their work creating an extremely valuable set of pharmacovigilance guidance documents.

The impact of CIOMS Working Groups on Global development pharmacovigilance has been substantial. Several ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, such as E2A, E2C, E2D and E2F, were based on respective CIOMS Working Groups work (see also the CIOMS Newsletter from June 2016).

ICH was established in 1992 and since 1996 the ICH E2B guideline have been developed to harmonize international electronic transmission of Individual Case Safety Reports (ICSRs), i.e. to standardize the data elements for the transmission of all types of ICSRs, regardless of source and destination. This includes case safety reports for both pre-approval and post-approval reporting periods and covers both adverse drug reaction (ADR) and adverse event (AE) reports. Today, most electronic exchange of ICSRs uses the ICH E2B standard and since the CIOMS I form is a reporting form, not primarily intended for electronic exchange between databases, linking the CIOMS I form to E2B can be helpful.